Effect of EARLY administration of DEXamethasone in patients with COVID-19 pneumonia without acute hypoxemic respiratory failure and risk of development of acute respiratory distress syndrome (EARLY-DEX COVID-19): study protocol for a randomized controlled trial.

BACKGROUND: Corticosteroids are one of the few drugs that have shown a reduction in mortality in coronavirus disease 2019 (COVID-19). In the RECOVERY trial, the use of dexamethasone reduced 28-day mortality compared to standard care in hospitalized patients with suspected or confirmed COVID-19 requiring supplemental oxygen or invasive mechanical ventilation. Evidence has shown that 30% of COVID-19 patients with mild symptoms at presentation will progress to acute respiratory distress syndrome (ARDS), particularly patients in whom laboratory inflammatory biomarkers associated with COVID-19 disease progression are detected. We postulated that dexamethasone treatment in hospitalized patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease might lead to a decrease in the development of ARDS and thereby reduce death. METHODS/DESIGN: This is a multicenter, randomized, controlled, parallel, open-label trial testing dexamethasone in 252 adult patients with COVID-19 pneumonia who do not require supplementary oxygen on admission but are at risk factors for the development of ARDS. Risk for the development of ARDS is defined as levels of lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L, and lymphocyte count of < 0.80 × 109/L. Eligible patients will be randomly assigned to receive either dexamethasone or standard of care. Patients in the dexamethasone group will receive a dose of 6 mg once daily during 7 days. The primary outcome is a composite of the development of moderate or more severe ARDS and all-cause mortality during the 30-day period following enrolment. DISCUSSION: If our hypothesis is correct, the results of this study will provide additional insights into the management and progression of this specific subpopulation of patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19.

Impact of Systemic Corticosteroids on Mortality in Older Adults With Critical COVID-19 Pneumonia.

BACKGROUND: The most susceptible population group to critical and fatal coronavirus disease 2019 (COVID-19) is older adults. In severe acute respiratory syndrome coronavirus 2 infection, the host immune response is thought to play a key role in the pathophysiological effects of lung damage. Therefore, corticosteroid therapy could modulate inflammation-mediated pulmonary injury and thereby reduce progression to severe respiratory failure and death. The aim of this study was to analyze the safety and clinical efficacy of corticosteroid therapy in older adults with severe COVID-19 pneumonia. METHOD: We reviewed the clinical records of confirmed COVID-19 patients aged 75 years or older admitted to our hospital over a 3-month period (March 1-May 31, 2020). A total of 143 patients were included in the study cohort. From 2 April, 2020, in accordance with World Health Organization guidance on COVID-19, our hospital protocol added corticosteroid for COVID-19 treatment. We compared in-hospital mortality among patients with critical COVID-19 who received corticosteroids therapy and those who did not. RESULTS: In total, 88 patients (61.5%) were treated with corticosteroids, and 55 patients (38.4%) were not. Both groups were similar in baseline characteristics. The median age was 85 years (interquartile range: 82-89), and 61.5% (88/143) were male. In-hospital mortality was lower in the corticosteroid group (68.2%) compared with patients in the noncorticosteroid group (81.8%). Treatment with corticosteroids was an independent survival factor (hazard ratio: 0.61; 95% CI: 0.41-0.93; p = .006). CONCLUSIONS: In critically ill older adults with COVID-19 pneumonia, the use of corticosteroid treatment resulted in lower mortality without severe adverse events.

Oral anticoagulation in patients with atrial fibrillation and medical non-neoplastic disease in a terminal stage.

Many patients with non-neoplastic disease develop atrial fibrillation in advanced stages of their disease. The aim of this study is to determine the factors associated with the use of oral anticoagulants in patients with atrial fibrillation and non-neoplastic medical disease in a terminal stage, and whether their use is associated with a longer survival. Design is prospective, observational, multicentre study. Patients with atrial fibrillation and non-neoplastic disease (severe not reversible organ insufficiency) in a terminal stage were included between February 2009 and September 2010. A 6-month follow-up was carried out. We included 314 patients with a mean (SD) age of 82.6 (7.0) years. Their mean (SD) scores in CHADS2 and ATRIA scales were 3.4 (1.2) and 4.7 (2.0), respectively. Anticoagulants were prescribed to 112 (37.5 %) patients. The use of anticoagulants was associated with age (OR 0.96 95 % CI 0.93-0.99, p = 0.046) and to the Barthel index (OR 1.01 95 % CI 1.00-1.02; p = 0.034). After performing a propensity score matching analysis, 262 patients were included in the survival analysis. After 6 months, 133 (50.8 %) patients were dead. The mortality is higher among patients who are not treated with oral anticoagulants (57.1 vs. 39.4 %; p = 0.006), but it is independently associated only with the Barthel index score (HR 0.99 95 % CI 0.98-1.00; p = 0.039), delirium (HR 1.60, 95 % CI 1.08-2.36; p = 0.018), anorexia (HR 1.58 95 % CI 1.05-2.38; p = 0.027), and with the use of calcium channel blockers (HR 0.50 95 % CI 0.30-0.84; p = 0.009). In patients with atrial fibrillation and non-neoplastic disease in a terminal stage, the use of oral anticoagulants is not independently associated with a higher probability of survival.

Development of a six-month prognostic index in patients with advanced chronic medical conditions: the PALIAR score.

CONTEXT: Efforts in developing useful tools to properly identify the end-of-life trajectory of patients with advanced medical diseases have been made, but the calibration and/or discriminative power of these tools has not been optimal. OBJECTIVES: Our objective was to develop a new, reliable prognostic tool to identify the probability of death within six months in patients with chronic medical diseases. METHODS: This was a multicenter, prospective, observational study in 41 Spanish hospitals, which included 1778 patients with one or more of the following: advanced conditions such as heart failure, respiratory failure, chronic renal failure, chronic liver disease, and/or chronic neurological disease. All patients were followed over six months. Each factor independently associated with death in the derivation cohort (884 patients from eastern areas of Spain) was assigned a prognostic weight, and the score was calculated by summing up the factors. The score's accuracy in the validation cohort (894 patients from western areas of Spain) was assessed by analyzing its calibration and discriminative power; we also calculated sensitivity, specificity, and positive and negative predictive values. RESULTS: Mortality in the derivation/validation cohorts was 37.6%/37.7%, respectively. We identified six independent predictors of mortality (≥85 years, three points; New York Heart Association Class IV/Stage 4 dyspnea on the modified Medical Research Council, 3.5 points; anorexia, 3.5 points; presence of pressure ulcer(s), three points; Eastern Cooperative Oncology Group Performance Status of three or more, four points; and albuminemia ≤2.5g/dL, four points). Mortality in the derivation/validation cohorts according to risk group was 20%/21.5% for patients with zero points; 33%/30.5% for those with 3-3.5 points; 46.3%/43% for those with four to seven points; and 67%/61% for those who reached 7.5 or more points, respectively. The calibration was good (Hosmer-Lemeshow test, P=0.39), as was the discriminative power (area under the receiver operating characteristic curve of 0.69 [0.66-0.72]). The sensitivity (85%), specificity (86%), positive and negative predictive values (64% and 80%, respectively) at 180 days were high. CONCLUSION: The PALIAR score is a precise and reliable tool for identifying the end-of-life trajectory in patients with advanced medical diseases.

Múltiples infartos isquémicos cerebrales como complicación de fiebre botonosa / Multiple cerebral ischemic infarcts as a complication of boutonneuse fever

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